Buerger's disease (also known as Thromboangiitis obliterans) is a recurring progressive inflammation and thrombosis (clotting) of small and medium arteries and veins of the hands and feet. One of the most common conditions arising due to Buerger's disease is Critical Limb Ischemia (CLI) that might result in amputation and limb loss.
CLI, an ischemic condition, is also a symptom of Peripheral Arterial Disease (PAD). Peripheral artery disease (PAD), also known as peripheral vascular disease (PVD) peripheral artery occlusive disease, and peripheral obliterative arteriopathy, is a condition resulting due to narrowing of arteries other than those that supply the heart or brain. Most commonly the legs and feet are affected. The classic symptom is leg pain when walking which resolves with rest. Other symptoms including: skin ulcers, bluish skin, cold skin, or poor nail and hair growth may occur in the affected leg. Complications may include an infection or tissue death which may lead to amputation, coronary artery disease, or stroke.
Symptoms of PAD in the legs and feet are generally divided into 2 categories:                Claudication—pain in muscles when walking or using the affected muscles that is relieved by resting those muscles. This is due to the unmet oxygen demand in muscles with use in the setting of inadequate blood flow; and        Critical limb ischemia, consisting of:                    Rest pain, a pain in the soles of the feet, particularly when the feet are elevated, such as when in bed.            Tissue loss, consisting of arterial insufficiency ulcers, which are sores or wounds that heal slowly or not at all, and Gangrene.                        
Incidence of critical limb ischemia is estimated to be approximately 500 to 1000 patients per million per year. CLI includes all patients with chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease. CLI arises as a result of atherosclerosis or vasculitis in leg arteries which severely impairs the patient functional status and quality of life and is associated with an increased cardiovascular mortality and morbidity. The annual overall major cardiovascular event rate [non-fatal myocardial infarction (MI), stroke and vascular death] in peripheral artery disease (PAD) patients is around 4-7%.
Narrowed vessels that cannot supply sufficient blood flow to exercising leg muscles may cause claudication, which is brought on by exercise and relieved by rest. As vessel narrowing increases, CLI can develop when the blood flow does not meet the metabolic demands of tissue at rest. 10% to 40% of the patients are at the risk of primary amputation.
Patients with CLI generally have a one and ten year mortality rates of approximately 20% and 75% respectively. Current mode of treatment has failed to show significant improvements in these “no-option” patients of CLI. Gradually the disease progresses resulting in gangrene and subsequently amputation of the affected limb at younger age. Prognosis of CLI is poor and no effective treatments have been established in patients who are not amenable for the traditional revascularization therapies (“no—option” patients) such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent re-occlusion following revascularization. Studies have shown that the amputation rate varies from 40% to 70% in these groups of patients with the standard protocol of care. Therefore, it is necessary to establish new revascularization treatments to improve prognosis of these patients.
Ischemic cardiomyopathy (ICM) is another ischemic condition which is the leading cause of cardiac failure worldwide. It leads to a great loss of productive years of life in people aged 40 and above. Chronic ischemia leads to myocardial cell death and ultimately loss of the myocardium, which in turn causes clinical heart failure and other dire consequences of arrhythmias and sudden cardiac death. Despite significant advances in medical therapy and interventional strategies, the prognosis of millions of patients with ischemic cardiomyopathy (ICM) and cardiac failure remains dismal.
The present disclosure aims to overcome the drawbacks observed in the currently available treatments for ischemic conditions by providing efficient Stromal cell therapy.